Open Prospective With Historical Control Clinical Study of 0.01 % Atropine Sulfate Effectiveness in Controlling of Myopia Progression in Children
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- change in axial length
研究概览
简要总结
Increasing number of myopic children and significant complications of high myopia enhance the necessity of effective control strategy. Instillations of low-dose atropine have been shown to reduce myopia progression in Asian populations but its effect in non-Asian populations is still unclear. This open prospective study with historical control is designed to investigate if 0.01% atropine can reduce myopia progression in Russian children, taking into account a change of difference between manifest and cycloplegic refraction, as well as, myopia progression rate at the time of recruitment.
详细描述
The study is designed to test the following hypotheses:
- 0.01% atropine one drop nightly is safe and with no significant side effects.
- nightly instillations of 0.01% atropine does not influence tear production.
- 0.01% atropine one drop nightly reduces the progression of childhood myopia in Russian children.
- nightly instillations of 0.01% atropine decreases the manifest refraction and, consequently, difference between manifest and cycloplegic refractions.
- effectiveness of 0.01% atropine depends on the age and myopia progression rate at the time the therapy was started.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •myopia progression rate of 0.5D or more per year;
- •myopia with astigmatism of 1.0D or less;
- •axial length and cycloplegic refraction data obtained 6 months before recruiting or earlier
- •signed informed consent.
排除标准
- •congenital myopia;
- •onset of myopia at 6 years old or earlier;
- •allergic reactions to any eye drops in anamnesis;
- •concomitant eye disorders, including strabismus.
结局指标
主要结局
change in axial length
时间窗: baseline - 12 months
Change in axial length elongation from baseline to 12 months, as measured using IOLMaster, compared with historical data
change in myopic progression rate
时间窗: baseline - 12 months
Change in myopic progression rate measured as the difference between cycloplegic refraction from baseline to 12 months, compared with historical data.
次要结局
- change in difference between manifest and cycloplegic refractions(baseline - 12 months)
- change in positive relative accommodation(baseline - 12 months)
- tear production(baseline - 12 months)
研究者
Daria Afanasyeva
Principal Investigator
The V.P. Vyhodcev Eye Hospital